Investor News

Acorda Therapeutics Reports First Quarter 2014 Financial Results

Reiterating Full Year 2014 Guidance for AMPYRA Net Revenue of
$328-$335 Million

Cash, cash equivalents and investments of $372.2 million as of March
31, 2014

ARDSLEY, N.Y.--(BUSINESS WIRE)--
Acorda Therapeutics, Inc. (Nasdaq:ACOR)
today announced its financial results for the first quarter ended March
31, 2014.

“The AMPYRA franchise remains strong, and we are reiterating our 2014
net sales guidance,” said
Ron Cohen
, M.D., Acorda Therapeutics’
President and CEO. “During the quarter, a fifth AMPYRA patent was issued
and listed in the Orange Book. AMPYRA’s commercial success is supporting
the development of an exciting pipeline of novel therapies. As
previously announced, we are planning to initiate a Phase 3 trial for
dalfampridine in post-stroke walking deficits in the second half of the
year. While we were disappointed to receive a Complete Response Letter
on PLUMIAZ™, we are working to address the FDA’s requests and refile our
NDA. We were pleased to resume enrollment of our second clinical trial
of GGF2 in chronic heart failure and to have completed the dose
escalation phase of our Phase 1 rHIgM22 trial for remyelination in MS,
with no serious or limiting adverse events.”

FINANCIAL RESULTS

The Company reported GAAP net income of $0.7 million for the quarter
ended March 31, 2014, or $0.02 per diluted share, compared to a GAAP net
loss in the same quarter of 2013 of $1.1 million, or $0.03 per diluted
share.

Non-GAAP net income for the quarter ended March 31, 2014 was $8.8
million, or $0.21 per diluted share. Non-GAAP net income in the same
quarter of 2013 was $1.3 million, or $0.03 per diluted share. Non-GAAP
net income excludes share based compensation charges and non-cash tax
adjustments. A reconciliation of the GAAP financial results to non-GAAP
financial results is included in the attached financial statements.

AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg - For the quarter
ended March 31, 2014, the Company reported AMPYRA net revenue of $72.5
million compared to $62.3 million for the same quarter in 2013.

ZANAFLEX CAPSULES®(tizanidine
hydrochloride), ZANAFLEX®
(tizanidine hydrochloride) tablets and authorized generic capsules
- For the quarter ended March 31, 2014, the Company reported combined
net revenue and royalties from ZANAFLEX and tizanidine of $3.1 million
compared to $4.4 million for the same quarter in 2013.

FAMPYRA®
(prolonged-release fampridine tablets) - For the quarter ended
March 31, 2014, the Company reported FAMPYRA royalties from sales
outside of the U.S. of $2.4 million, compared to $2.9 million for the
same quarter in 2013. Royalties in 2013 included a favorable adjustment
of $1.0 million from the establishment of pricing in Germany.

Research and development (R&D) expenses
for the quarter ended March 31, 2014 were $14.5 million, including $1.1
million of share-based compensation, compared to $12.5 million including
$1.2 million of share-based compensation for the same quarter in 2013.

Sales, general and administrative (SG&A) expenses
for the quarter ended March 31, 2014 were $46.9 million, including $4.7
million of share-based compensation, compared to $48.2 million including
$3.8 million of share-based compensation for the same quarter in 2013.

The Company is reiterating its 2014 R&D and SG&A expense guidance, and
is evaluating the impact of recent events on both R&D and SG&A expenses
for 2014. The Company will provide an update on its next earnings call
if there are any changes to guidance.

Provision for income taxes for the quarter
ended March 31, 2014 was $2.8 million, including $0.4 million of cash
taxes, compared to a tax benefit of $1.8 million, including $0.7 million
of cash taxes for the same quarter in 2013.

At March 31, 2014 the Company had cash, cash equivalents and short-term
and long-term investments of $372.2 million.

A new U.S. AMPYRA patent was issued by the U.S. Patent and Trademark
Office (USPTO) in early 2014. The Company now has five Orange Book
patents providing protection up to 2027.

PIPELINE UPDATE

In May, the U.S. Food and Drug Administration (FDA) issued a Complete
Response Letter (CRL) for the New Drug Application (NDA) for PLUMIAZ™
(diazepam) Nasal Spray for the treatment of people with epilepsy who
experience cluster seizures. The Company is evaluating the CRL and
expects to work closely with the FDA to address the items outlined in
the letter, which will include additional clinical work, and refile
the NDA. Based on the requirements noted in the letter, the Company
does not expect PLUMIAZ to receive FDA approval in 2014.

In April, the Company announced that additional data on QD
(once-daily) dalfampridine extended release tablets are needed before
starting a Phase 3 trial in post-stroke walking deficits, and now
expects to begin the trial in the second half of 2014. Previously the
Company had projected study initiation in the second quarter of 2014.
The developer of the once-daily formulation informed the Company of an
alcohol dose dumping finding in vitro and the Company will need to
perform a short clinical study to determine whether this also exists
in vivo. The clinical study will be conducted in healthy volunteers
and is expected to be completed in the third quarter of 2014.

In April, the Company announced that it has completed its review of
certain preclinical data and that the Phase 1b clinical trial of GGF2
in chronic heart failure will resume recruitment. The
single-intravenous infusion trial is assessing tolerability of three
dose levels of GGF2 and also includes several exploratory efficacy
measures. The Company expects that the trial will be completed in 2015.

The Company has completed the dose escalation portion of the Phase 1b
rHIgM22 clinical trial, with no serious or limiting adverse events
reported. The second portion of this study will explore safety,
tolerability and efficacy endpoints for six months in additional
patients at the two highest doses achieved in the dose escalation
portion of the trial. Enrollment in the second part of the trial is
almost complete.

To participate in the conference call, please dial 800-706-7745
(domestic) or 617-614-3472 (international) and reference the access code
66119945. The presentation will be available via a live webcast on the
Investor section of www.acorda.com.

A replay of the call will be available from 12:30 p.m. ET on May 6, 2014
until midnight on June 3, 2014. To access the replay, please dial
888-286-8010 (domestic) or 617-801-6888 (international) and reference
the access code 83511569. The archived webcast will be available for 30
days in the Investor Relations section of the Acorda website at www.acorda.com.

Important Safety Information

Do not take AMPYRA if you:

have ever had a seizure,

have certain types of kidney problems, or

are allergic to dalfampridine (4-aminopyridine), the active ingredient
in AMPYRA.

Take AMPYRA exactly as prescribed by your doctor.

Before taking AMPYRA, tell your doctor if you:

have kidney problems or any other medical conditions,

are taking compounded 4-aminopyridine,

are pregnant or plan to become pregnant. It is not known if AMPYRA
will harm your unborn baby.

are breast-feeding or plan to breast-feed. It is not known if AMPYRA
passes into your breast milk. You and your doctor should decide if you
will take AMPYRA or breast-feed. You should not do both.

are taking any other medicines

Stop taking AMPYRA and call your doctor right away if you have a seizure
while taking AMPYRA. You could have a seizure even if you never had a
seizure before. Your chance of having a seizure is higher if you take
too much AMPYRA or if your kidneys have a mild decrease of function,
which is common after age 50. Your doctor may do a blood test to check
how well your kidneys are working before you start AMPYRA.

AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP,
fampridine), since the active ingredient is the same.

AMPYRA may cause serious side effects, including:

severe allergic reactions. Stop taking AMPYRA and call your doctor
right away or get emergency medical help if you have shortness of
breath or trouble breathing, swelling of your throat or tongue, or
hives;

kidney or bladder infections.

The most common adverse events for AMPYRA in MS patients were urinary
tract infection, trouble sleeping, dizziness, headache, nausea,
weakness, back pain, and problems with balance.

AMPYRA is a potassium channel blocker approved as a treatment to improve
walking in patients with multiple sclerosis (MS). This was demonstrated
by an increase in walking speed. AMPYRA, which was previously referred
to as Fampridine-SR, is an extended release tablet formulation of
dalfampridine (4-aminopyridine, 4-AP), and is known as prolonged-,
modified, or sustained-release fampridine (FAMPYRA®) in some
countries outside the United States (U.S.).

In laboratory studies, dalfampridine extended release tablets has been
found to improve impulse conduction in nerve fibers in which the
insulating layer, called myelin, has been damaged. AMPYRA is being
developed and commercialized in the U.S. by Acorda Therapeutics; FAMPYRA
is being developed and commercialized by Biogen Idec in markets outside
the U.S. based on a licensing agreement with Acorda. AMPYRA and FAMPRYA
are manufactured globally by Alkermes Pharma Ireland Limited, a
subsidiary of Alkermes plc, based on a supply agreement with Acorda.

AMPYRA is available by prescription in the United States. For more
information about AMPYRA, including patient assistance and co-pay
programs, healthcare professionals and people with MS can contact AMPYRA
Patient Support Services at 888-881-1918. AMPYRA Patient Support
Services is available Monday through Friday, from 8:00 a.m. to 8:00 p.m.
Eastern Time.

For full U.S. Prescribing Information and Medication Guide, please
visit: www.AMPYRA.com.

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biotechnology company focused
on developing therapies that improve the lives of people with
neurological disorders.

Acorda markets three FDA-approved therapies including: AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg, a treatment to improve
walking in patients with multiple sclerosis (MS); ZANAFLEX
CAPSULES® (tizanidine hydrochloride) and Zanaflex
tablets, a short-acting drug for the management of spasticity; and QUTENZA®
(capsaicin) 8% Patch, for the management of neuropathic pain associated
with postherpetic neuralgia. AMPYRA is marketed outside the United
States as FAMPYRA® (prolonged-release fampridine tablets) by
Biogen Idec under a licensing agreement from Acorda.

Acorda has one of the leading pipelines in the industry of novel
neurological therapies. The Company is currently developing six
clinical-stage therapies and one preclinical stage therapy that address
a range of disorders including post-stroke deficits, epilepsy, stroke,
peripheral nerve damage, spinal cord injury, neuropathic pain, and heart
failure. For more information, please visit the Company’s website at: www.acorda.com.

Forward-Looking Statements

This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects should be
considered forward-looking. These statements are subject to risks and
uncertainties that could cause actual results to differ materially,
including our ability to successfully market and sell Ampyra in the
U.S.; third party payers (including governmental agencies) may not
reimburse for the use of Ampyra or our other products at acceptable
rates or at all and may impose restrictive prior authorization
requirements that limit or block prescriptions; the risk of unfavorable
results from future studies of Ampyra or from our other research and
development programs, including Plumiaz (our trade name for Diazepam
Nasal Spray), or any other acquired or in-licensed programs; we may not
be able to complete development of, obtain regulatory approval for, or
successfully market Diazepam Nasal Spray or other products under
development; the occurrence of adverse safety events with our products;
delays in obtaining or failure to obtain regulatory approval of or to
successfully market Fampyra outside of the U.S. and our dependence on
our collaboration partner Biogen Idec in connection therewith;
competition, including the impact of generic competition on Zanaflex
Capsules revenues; failure to protect our intellectual property, to
defend against the intellectual property claims of others or to obtain
third party intellectual property licenses needed for the
commercialization of our products; failure to comply with regulatory
requirements could result in adverse action by regulatory agencies; and
the ability to obtain additional financing to support our operations.
These and other risks are described in greater detail in Acorda
Therapeutics' filings with the Securities & Exchange Commission. Acorda
may not actually achieve the goals or plans described in its
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in this
release are made only as of the date hereof, and Acorda disclaims any
intent or obligation to update any forward-looking statements as a
result of developments occurring after the date of this release.

Non-GAAP Financial Measures

This press release includes financial results prepared in accordance
with accounting principles generally accepted in the United States
(GAAP), and also certain historical and forward-looking non-GAAP
financial measures. In particular, Acorda has provided income, adjusted
to exclude share-based compensation charges and non-cash taxes. These
non-GAAP financial measures are not an alternative for financial
measures prepared in accordance with GAAP. However, the Company believes
the presentation of these non-GAAP financial measures when viewed in
conjunction with our GAAP results, provide investors with a more
meaningful understanding of our ongoing and projected operating
performance because they exclude non-cash charges and benefits that are
substantially dependent on changes in the market price of our common
stock or relate to tax accounting, and expenses that do not arise from
the ordinary course of our business. The Company believes these non-GAAP
financial measures help indicate underlying trends in the company’s
business and are important in comparing current results with prior
period results and understanding projected operating performance. Also,
management uses these non-GAAP financial measures to establish budgets
and operational goals, and to manage the company’s business and to
evaluate its performance. A reconciliation of the historical non-GAAP
financial results presented in this release to our GAAP financial
results is included in the attached financial statements.

Financial Statements

Acorda Therapeutics, Inc.

Condensed Consolidated Balance Sheet Data

(in thousands)

(Unaudited)

March 31,

December 31,

2014

2013

Assets

Cash, cash equivalents, short-term and long-term investments

$

372,152

$

367,227

Trade receivable, net

29,265

30,784

Other current assets

16,087

17,135

Finished goods inventory

31,154

26,172

Property and equipment, net

16,440

16,525

Deferred tax asset

124,478

127,299

Intangible assets, net

17,959

17,459

Other assets

4,352

4,526

Total assets

$

611,887

$

607,127

Liabilities and stockholders' equity

Accounts payable, accrued expenses and other liabilities

$

52,837

$

53,491

Deferred product revenue

31,217

32,090

Current portion of deferred license revenue

9,057

9,057

Current portion of notes payable

1,144

1,144

Current portion of revenue interest liability

450

861

Long-term liabilities

8,788

9,863

Non-current portion of revenue interest liability

511

640

Non-current portion of deferred license revenue

57,363

59,628

Stockholders' equity

450,520

440,353

Total liabilities and stockholders' equity

$

611,887

$

607,127

Acorda Therapeutics, Inc.

Consolidated Statements of Operations

(in thousands, except per share amounts)

(Unaudited)

Three Months Ended

March 31,

2014

2013

Revenues:

Net product revenues

$

74,463

$

64,084

Royalty revenues

3,791

5,516

License revenue

2,264

2,265

Total revenues

80,518

71,865

Costs and expenses:

Cost of sales

15,529

13,484

Cost of license revenue

159

159

Research and development

14,522

12,520

Selling, general and administrative

46,892

48,198

Total operating expenses

77,102

74,361

Operating income (loss)

$

3,416

$

(2,496

)

Other income (expense), net

80

(418

)

Income (loss) before income taxes

3,496

(2,914

)

(Provision for) benefit from income taxes

(2,793

)

1,775

Net income (loss)

$

703

$

(1,139

)

Net income (loss) per common share - basic

$

0.02

$

(0.03

)

Net income (loss) per common share - diluted

$

0.02

$

(0.03

)

Weighted average per common share - basic

40,934

39,832

Weighted average per common share - diluted

42,235

39,832

Acorda Therapeutics, Inc.

Non-GAAP Income and Income per Common Share Reconciliation

(in thousands, except per share amounts)

(Unaudited)

Three Months Ended

March 31,

2014

2013

GAAP net income (loss)

$

703

$

(1,139

)

Pro forma adjustments:

Non-cash taxes (1)

2,333

(2,506

)

Share-based compensation expenses included in R&D

1,104

1,151

Share-based compensation expenses included in SG&A

4,653

3,782

Total share-based compensation expenses

5,757

4,933

Total pro forma adjustments

8,090

2,427

Non-GAAP net income

$

8,793

$

1,288

Net income per common share - basic

$

0.21

$

0.03

Net income per common share - diluted

$

0.21

$

0.03

Weighted average per common share - basic

40,934

39,832

Weighted average per common share - diluted

42,235

41,038

(1) $460,000 and $731,000 paid in cash taxes in 2014 and 2013,
respectively. 2013 revised to include a non-cash tax adjustment to
conform with current year presentation.